ProGripTM Self-Gripping Polyester Mesh in Incisional Hernia Prevention (POETRY)

Medtronic

Status

Terminated

Conditions

Incisional Hernia

Treatments

Device: Mesh augmented reinforcement

Study type

Interventional

Funder types

Industry

Identifiers

NCT03912662

MDT17048POETRY

Details and patient eligibility

About

Interventional, prospective, multicenter, post-marketing clinical follow-up study.

After midline laparotomy, the probability to develop an incisional hernia ranges from 10% to 50% depending on the complexity of the surgery and patient state of health.

As the clinical data needed for the study corresponds with those collected by Club Hernie registry, the clinical study will use the established registry database to collect performance and safety data on the prevention of incisional hernias within 24 months post operatively.

Full description

The primary objective of this investigation is to confirm the efficacy of ProGrip™ Self-gripping Polyester Mesh to reduce the incidence of incisional hernia within 24 months post-operatively in subjects undergoing procedures with midline laparotomies.

Secondary Objective The secondary objective of this investigation is to confirm the safety of ProGrip™ Self-gripping Polyester Mesh through the occurrence of adverse device effects or procedure related adverse events following the use of ProGrip™ Self- gripping Polyester Mesh in subjects undergoing procedures with midline laparotomies.

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject has provided informed consent.
Subject is ≥ 18 years of age at the time of consent.
Subject will be undergoing an elective midline laparotomy.
Subject may have a combination of low- and high-risk factors but cannot exceed a total of 5 risk factors or have more than 2 high-risk factors. Subject must have at least 2 low-risk factors if subject does not have any high-risk factors. High- and low-risk factors include:
1. High-Risk Factors (maximum of 2): i.BMI≥ 35; ii.Prior open abdominal surgery; iii.Daily active smoker or Chronic Obstructive Pulmonary disease (COPD) diagnosis; iv. Current or recent (within 1 year) cancer diagnosis or chemotherapy treatment; v.History of or current abdominal aorta aneurism or surgery for abdominal aortaaneurism
2. Low-Risk Factors (minimum of 2, if no high-risk factors): i.25 ≤ BMI < 35; ii.Age > 45; iii.Uncontrolled diabetes; iv.Malnutrition as defined by 10% weight loss within the last 3 months; v.Current immunosuppressive treatment; vi.Undergoing colorectal surgery

Exclusion criteria

Subject is undergoing emergency surgery, i.e. lifesaving procedures performed where subject is in imminent danger of death.
Subject for which the device is used outside the product IFU, including;
1. Pregnant women: Women who are known or suspected to be pregnant, or who are planning to become pregnant during the study follow-up period
2. Subject who has an infection within 30 days of enrollment or, at the time of the surgery, has any active, acute or chronic infection(s) that are uncontrolled and/or requiring treatment such as antibiotics
3. Subject whose surgical site is contaminated or dirty/infected intraoperatively, as assessed by the Investigator (Exclude Altemeier classification III-IV).
Subject who had received a mesh in a previous ventral hernia repair or has a ventral hernia.
Investigator determined that a planned future surgery would interfere with application of mesh reinforcement.
Subject has participated in an investigational drug or device research study within 30 days of enrollment.
Subject has a life expectancy of <2 years.
Subject has an ASA Physical Status Classification System score >3.
Subject has >5 total risk factors or >2 high-risk factors